Trial · NCT02606045
Minimize Menorrhagia in Women With Von Willebrand Disease
NCT02606045, Phase 3, Terminated, Margaret Ragni; results first posted 2024-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Minimize Menorrhagia in Women With Von Willebrand Disease. Trials, record NCT02606045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02606045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Minimize Menorrhagia in Women With Von Willebrand Disease
- NCT number
- NCT02606045
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 39 participants, actual
- Lead sponsor
- Margaret Ragni
- Conditions
- Von Willebrand Diseases
- Interventions
- recombinant von Willebrand factor, tranexamic acid
- First posted
- 2015-11-17
- Last updated
- 2024-07-01
- Results first posted
- 2024-07-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Menstrual Bleeding Severity | 4 weeks. | As measured by Pictorial Blood Assessment Chart (PBAC), 0- no theoretical limit, higher score means greater severity |
| Secondary | Cycle Duration | 4 weeks. | Menorrhagia cycle length by days of bleeding (score 0 - theoretically any length) |
| Secondary | Ruta Menorrhagia Severity Scale | 4 weeks. | Unit measure derived from quality of life questions reported as a single score, Minimum 0 to 100 maximum, with a higher score indicating worse outcome |
| Secondary | Center for Epidemiology Studies Depression Scale (CES-D) | 4 weeks. | Reported by questions on depression, Minimum 0 to 60 Maximum, with higher scores indicating greater depression. |
| Secondary | Rand Short Form 36-Question Health Survey (SF-36) | 4 weeks | SF-36 reported by answer to questions, Minimum 0 to Maximum 100 for each of 8 domains (1-physical functioning, 2-role limitations due to physical health, 3-role limitations due to emotional problems, 4-energy and fatigue, 5-emotional wellbeing, 6-social functioning, 7-pain, and 8-general health), with higher scores for each domain meaning greater severity of physical and mental health. |
| Secondary | Center for Disease Control Health-Related Quality of Life 14 Questions (CDC-HRQoL-14) | 4 weeks. | Reported by answer to questions, over the past two weeks with minimum 0 to maximum 14, with higher scores indicating greater severity of physical and mental health. |
| Secondary | Cycle Severity | 4 weeks | Menorrhagia cycle severity by Likert scale, with minimum 0 to maximum 3, with higher score indicating worse severity. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Menstrual Bleeding Severity | 4 weeks. | score on a scale | MEAN | |
| SECONDARY | Cycle Duration | 4 weeks. | days | MEAN | |
| SECONDARY | Ruta Menorrhagia Severity Scale | 4 weeks. | units on a scale | MEAN | |
| SECONDARY | Center for Epidemiology Studies Depression Scale (CES-D) | 4 weeks. | score on a scale | MEAN | |
| SECONDARY | Rand Short Form 36-Question Health Survey (SF-36) | 4 weeks | units on a scale | MEAN | |
| SECONDARY | Center for Disease Control Health-Related Quality of Life 14 Questions (CDC-HRQoL-14) | 4 weeks. | units on a scale | MEAN | |
| SECONDARY | Cycle Severity | 4 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Menstrual Bleeding Severity | Tranexamic Acid | 225 | Standard Deviation 207 | score on a scale | |
| Menstrual Bleeding Severity | Recombinant Von Willebrand Factor | 272 | Standard Deviation 223 | score on a scale | |
| Cycle Duration | Tranexamic Acid | 7.1 | Standard Deviation 4.5 | days | |
| Cycle Duration | Recombinant Von Willebrand Factor | 7.0 | Standard Deviation 3.9 | days | |
| Ruta Menorrhagia Severity Scale | Tranexamic Acid | 32.4 | Standard Deviation 13.5 | units on a scale | |
| Ruta Menorrhagia Severity Scale | Recombinant Von Willebrand Factor | 34.8 | Standard Deviation 13.0 | units on a scale | |
| Center for Epidemiology Studies Depression Scale (CES-D) | Tranexamic Acid | 13.5 | Standard Deviation 10.6 | score on a scale | |
| Center for Epidemiology Studies Depression Scale (CES-D) | Recombinant Von Willebrand Factor | 11.0 | Standard Deviation 10.2 | score on a scale | |
| Rand Short Form 36-Question Health Survey (SF-36) | Tranexamic Acid | Physical functioning | 84.4 | Standard Deviation 19.6 | units on a scale |
| Rand Short Form 36-Question Health Survey (SF-36) | Recombinant Von Willebrand Factor | Physical functioning | 83.6 | Standard Deviation 20.0 | units on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recombinant Von Willebrand Factor, Then Tranexamic Acid | 18 | |
| Overall Study | STARTED | Tranexamic Acid Then Recombinant Von Willebrand Factor | 21 | |
| Overall Study | COMPLETED | Recombinant Von Willebrand Factor, Then Tranexamic Acid | 17 | |
| Overall Study | COMPLETED | Tranexamic Acid Then Recombinant Von Willebrand Factor | 19 | |
| Overall Study | NOT COMPLETED | Recombinant Von Willebrand Factor, Then Tranexamic Acid | 1 | |
| Overall Study | NOT COMPLETED | Tranexamic Acid Then Recombinant Von Willebrand Factor | 2 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mucosal Bleeding | Blood and lymphatic system disorders | Tranexamic Acid | 2 | 36 | 4 |
| other | Mucosal Bleeding | Blood and lymphatic system disorders | Recombinant Von Willebrand Factor | 0 | 36 | 0 |
| other | Other Bleeding | Blood and lymphatic system disorders | Tranexamic Acid | 3 | 36 | 4 |
| other | Other Bleeding | Blood and lymphatic system disorders | Recombinant Von Willebrand Factor | 2 | 36 | 2 |
| other | Hematoma | Blood and lymphatic system disorders | Tranexamic Acid | 0 | 36 | 0 |
| other | Hematoma | Blood and lymphatic system disorders | Recombinant Von Willebrand Factor | 1 | 36 | 1 |
| other | Injury/ Trauma Bleeding | Blood and lymphatic system disorders | Tranexamic Acid | 0 | 36 | 0 |
| other | Injury/ Trauma Bleeding | Blood and lymphatic system disorders | Recombinant Von Willebrand Factor | 1 | 36 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tranexamic Acid | 0 | 36 |
| Total, all-cause mortality | Recombinant Von Willebrand Factor | 0 | 36 |
| Total, other adverse events | Tranexamic Acid | 4 | 36 |
| Total, other adverse events | Recombinant Von Willebrand Factor | 4 | 36 |
| Total, serious adverse events | Tranexamic Acid | 0 | 36 |
| Total, serious adverse events | Recombinant Von Willebrand Factor | 0 | 36 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL133815 | Von Willebrand Disease Minimize Menorrhagia (VWDMin) Trial | RAGNI, MARGARET VICTORIA | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2017 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tranexamic Acid vs Recombinant Von Willebrand Factor: deaths from any cause | Trial comparisons |
| Tranexamic Acid vs Recombinant Von Willebrand Factor: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02606045
GET https://conductscience.org/api/trials/v1/NCT02606045/results?page=2